White paper: Computer System Validation
|
|
- Beatrix Edwards
- 7 years ago
- Views:
Transcription
1 White paper: Computer System Validation This White Paper will assist and guide you with the validation of computer systems, using GAMP 5 methodologies. This document was prepared in February 2016, any content including links and quoted regulation may be out of date. Please refer to the appropriate source for the most recent information. We endeavour to keep an up-to-date record of information at
2 Introduction This whitepaper is intended as a guide to assist your organization with Computer System Validation (CSV) and provides an overview of CSV methodologies and a road map of deliverables used in the CSV process. As computer systems are diverse, depending on the type and size of system, novelty, complexity and business impact, the deliverables may be scaled up or down accordingly. The CSV process discussed in this whitepaper is based on the GAMP 5 framework, as it provides an excellent and pragmatic approach for CSV which, when followed, will ensure your computerized systems are fit for purpose, will meet the needs of your business, and are compliant with current regulations. Validation Process The range of activities required to validate a computerized system are determined by its GAMP 5 software and hardware categorization, GxP impact, applicable electronic records and electronic signatures requirements,and its risk-based lifecycle approach. There are four life cycle phases of a computer system which are employed by GAMP 5 - concept, project, operation and retirement. Various activities take place in more than one phase, hence a fifth phase, multi-phase, is documented here to describe these cross phase activities. Concept Phase System Software and Hardware Categorization The following GAMP 5 software and hardware categories are used to establish the validation approach and determine the deliverables: Category 1 Infrastructure Software Category 3 Non-Configured Products Category 4 Configured Products Category 5 Custom Applications Hardware Category 1 Standard Hardware Components Hardware Category 2 Custom Built Hardware Components GxP Impact Assessment The GxP impact assessment is carried out to determine if the computer system has an impact on product quality, patient safety or data integrity. All GxP impact computer systems must comply with applicable regulatory requirements. Page 2 of 14
3 Electronic Records and Electronic Signatures (ERES) Assessment An assessment is carried out to establish if the system needs to meet the requirements of electronic records and electronic signatures by determining what electronic records are created by the system, how those records are maintained and how the records will be signed, either by hand or electronically. Project Phase Supplier Assessment The system supplier must be assessed to determine their suitability to provide a quality system that meets all requirements. Confidence will be gained through their adherence to a documented Quality Management System and Software Development Life Cycle (SDLC). The assessment may take the form of a basic checklist, a postal questionnaire, or an onsite audit, depending on the outcome of the risk assessment. Supplier selection should then be documented in a report, along with whether the supplier documentation will be leveraged or not. Risk Management Risk assessments should be performed at various key stages of the validation process by a multidisciplinary team so that a full understanding of all processes and requirements are covered and taken into account. This helps to identify and manage risks to patient safety, product quality and data integrity. An initial risk assessment is conducted early on in the project phase so that the results can be used in the validation plan, along with the outcome of activities in the concept phase, to define the depth and rigor of required activities and compile a list of deliverables. This produces a validation approach which is commensurate with the level of risk the system poses. A functional risk assessment is performed following approval of the functional specification to identify potential risks. Mitigation activities are then planned to manage the identified risks and allow focusing on critical areas, e.g.by modifying functionality, detailed testing, procedural controls or training. Further risk assessments can be performed during the course of the project such as testing and deployment, and for other activities throughout the life of the system. A risk assessment uses a simple scoring system documented in a matrix to produce the level of risk. A maximum scoring of 1 to 3 and low, medium and high are used to judge the severity of the risk, likelihood of occurrence and the probability of detection to attain an overall risk level. Validation Plan (VP) The Validation Plan (VP) is produced to define the validation approach, describe the required activities, detail the acceptance criteria and list the deliverables and responsibilities. The VP specifies how flexible and scalable the validation approach will be which is derived from the outcome of activities in the concept phase. Page 3 of 14
4 System Overview The system overview is a brief description of the system and includes: System identification Business processes the system supports Data managed by the system High level functionality of the system High level schematic diagram of system architecture/hardware All interfaces to external systems How data is secured by physical or electronic means The system overview may be incorporated into a section of the VP. User Requirements Specification (URS) The User Requirements Specification (URS) clearly and precisely states what the user wants the system to do, what attributes it should have and details any non-functional requirements and constraints. The following areas should be considered: Operational and data requirements Regulatory requirements including ERES Interfaces System access & security Data handling and reporting System capability Environmental health and safety Supplier support documentation and testing Functional Specification (FS) The Functional Specification (FS) defines the full system functionality including how the user and business requirements are satisfied. It is the basis for system design, customization, development and testing. Supplier documentation should be leveraged wherever possible or referenced from the FS. It must be clear how the requirements are met from the URS and provide sufficient information to allow the design specification to be written. The FS may be combined with the URS as a Functional Requirement Specification (FRS). Configuration Specification (CS) The Configuration Specification details the configuration parameters and how these settings address the requirements in the URS. This may be a standalone document or detailed in the FS. Page 4 of 14
5 Design Specification (DS) This activity involves documenting both the hardware and software as a combined document (DS) or for larger systems as two separate specifications, Hardware Design Specification (HDS) and Software Design Specification (SDS). It can be merged with the Functional Specification as the Functional Design Specification (FDS). Design Review (DR) Design Reviews are conducted to verify that the design conforms to required standards; the FS meets the requirements defined in the URS and that the requirements can be traced through the design documents in preparation for testing. The output from the risk assessment is also considered in the review process. A design review report documents the outcome of the design review process. Software Development This is a process where source code is planned and written in accordance with pre-defined programming standards. Code Review If applicable, a code review is performed to detect and fix coding errors before the system goes into formal testing. It verifies that the software has been developed in accordance with the design and programming standards have been followed. Data Migration A Data Migration Plan is created when a system requires data loading from an existing system. It describes the activities and deliverables required to select, remove, cleanse, migrate and verify all data to assure its security and integrity. Data can be manually or automatically loaded/migrated, however if any critical data has been manually entered, an evaluation should be carried out to ensure its correctness. Testing Testing is carried out to verify that installation and configuration has been conducted in line with specifications and that the functionality is challenged at subsystem and system level. This verifies that system components perform their tasks separately, that the subsystems integrate correctly and that the system meets the requirements and expectations of its users. The testing approach is described in a test plan as either a section within the validation plan or as a standalone document. Where possible at each stage, any previous testing should be leveraged, which is defined in the plan. The plan also defines the different types and details the level of testing (e.g. installation, unit, system, acceptance) that will be required for a project. The results from the outcome of the risk assessment will define how precise the depth and rigor of testing shall be and the level of testing will be scaled appropriately. The plan will specify the test environment (development, test, or production) in which testing shall be performed, the use of any tools to be employed for testing and test data requirements. Page 5 of 14
6 The installation verification, functional verification and requirements verification testing documents are generated against pre-approved specifications. Test cases are written in test steps as instructions to be followed to test whether the system satisfies the defined acceptance criteria appropriate for the test level. The test steps are written in sufficient detail so that testing is repeatable with consistent results. A printed copy of the approved test case document is executed and the test steps annotated to record the test results. Verification against the expected result defines whether the test step is a pass or fail. Evidence produced during test execution (e.g. reports or screen prints) is attached to allow an independent review and approval of the results. Test results are reviewed, summarized and approved as a standalone test report or as part of the executed document. System Operating Procedures / User Manuals System Operating Procedures should be written to provide clear unambiguous instructions to personnel as to the accepted process of completing a particular operation in a systematic, consistent and safe manner. User manuals should be leveraged wherever possible. Training Key users must be trained in the use of the system software, applications and procedures as necessary for the development, maintenance, testing and support of the system. System Support Plan A System Support Plan defines the supporting organizations and procedures to support and maintain the quality/validation of the system during its operation phase. Service Level Agreement (SLA) A Service Level Agreement (SLA) documents a mutual agreement for the service provided between all parties. It should clearly define service, document and data ownership and ensure accountability, roles and responsibilities are established. The escalation process should be fully described along with the service performance criteria. Handover A plan should be written to define when the application will transition into the operation phase and how any disruption will be managed. The risk management process could be used in this process together with a back out plan. It should ensure that project and validation / verification deliverables are complete prior to handover. Page 6 of 14
7 System Release When the system is ready to be released for routine use, a certification statement is created detailing the following: System name and version Date of release Department using the system The activities and deliverables relating to the release Restrictions on use (if any) Open incidents (if any) Deployment Planning Deployment activities include the installation, configuration, data migration and testing of the system and components on the final operating environment (production). Validation Report (VR) The Validation Report (VR) summarizes the activities carried out during the project, describes any deviations, with justification, from the Validation Plan (VP), lists any limitations or restrictions on use, summarizes any incidents and details any outstanding and corrective actions. A certification statement concludes whether the validation was successful or not and approves or declines the system for its intended routine use. An Interim Validation Report may be issued if all post go-live activities are not complete. Page 7 of 14
8 Operation Phase The computer system is now in operation. In order for it to maintain its validated status, all aspects of the system and operating environment must be kept in a documented state of control. The following activities will assist in this phase. Backup and Restore Backup and restore is a routine process consisting of copying software, data and electronic records to a separate safe and secure area. This information is protected, available and when required, able to be restored, uncorrupted in its original format. Backup and restore is not the same as the archiving and retrieval processes. Continuity Planning and Testing / Disaster Recovery The continuity plan defines the approach to test all or part of a system s restoration process. This verifies the activities required to get a system or its component parts in an operating condition again in the event of a disaster. Periodic continuity testing should be conducted as a tabletop or full test to verify recovery processes are up to date. A schedule is created to detail the test type and frequency depending on system criticality and risk. Periodic Review The cumulative effect of changes to a system could affect its validated status. Periodic reviews are performed to ensure that the computer system remains within both company and regulatory compliance, and is fit for its intended use. The review evaluates the compliance status of the entire system and plans any required corrective action activities. The frequency of review depends on such things as system criticality, risk, business impact and complexity; however the frequency interval is generally not greater than 3 years. Data Archive & Retrieval Data archiving is the process of removing data and electronic records that is no longer actively used to a separate, secure data storage area for long-term retention. Data that must be retained for regulatory compliance has to be archived and be available for retrieval when required. Records retention requirements should also be considered with respect to the protection, preservation, and confidentiality of electronic records, including their associated audit trail information. Archiving and retrieval is not the same as the backup and restore processes. Page 8 of 14
9 Retirement Phase Decommissioning A decommissioning plan must be prepared for systems that are to be retired from operational service so that the process is documented and controlled. Consideration must be taken into account with regards to the archiving of data and records retention requirements, along with any hardware disposal. Multi-Phase Requirements Traceability Traceability must be documented to identify the connection between the results of the risk assessment, via the requirements specification, design and through all testing to individual test cases. Change Management The change management process defines the requirements for assessing, documenting and managing changes to ensure systems remain in a validated state and applies to software, hardware, configuration data and documentation. The process requires all planned and unplanned changes to be planned, assessed, executed and closed in a controlled and compliant manner. Project change control is used to manage changes made to any approved primary design documents, project scope changes or changes that will have an effect on product quality, patient safety, data integrity, project cost or schedule. Incident / Deviation Management The incident / deviation management process defines the requirements for managing incidents / deviations for the entire system lifecycle. It details the recording, analyzing, resolution and closure of faults, anomalies and problems that have been identified during the project phase, testing and operation of the system. Incident logs should be created to allow the collection and tracking of incidents. Document Management The document management process defines the lifecycle controls for documentation including the creation, review, approval, storage, archiving and distribution of documents. It describes how documents are classified, named, numbered and maintained, and also the mechanism for updating them. It is applicable to both hard copy (paper) and soft copy (electronic) documents. Page 9 of 14
10 Configuration Management The configuration management process defines the identification, control and status for configuration items (e.g. software, objects) which are under change and version control; as well as the controls, procedures, tools and processes to manage the configuration modifications. Access and Security Management The access and security management process defines the requirements for the security and integrity of a system. Physical and logical security protection mechanisms should secure the system and data against deliberate or accidental loss, damage or unauthorized change. Access requests and permissions should be defined with regard to the initiation, authorization, amending, revoking, recording and auditing of access rights. Validation Deliverables Checklist Deliverable Multi Phase Requirements Traceability Matrix Change Management Access and Security Management Document Management Incident / Deviation Management Configuration Management Concept Phase GxP Impact Assessment System Software and Hardware Categorization Electronic Records and Electronic Signatures Assessment Project Phase Supplier Assessment Required? (Yes / No) Complete? (x / ) Page 10 of 14
11 Deliverable Risk Assessment Business Requirements / Process Requirements System Requirements User Requirements Specification System Overview Validation Plan Configuration Specification Functional Specification Functional Design Specification Hardware Design Specification Software Design Specification Unit Specification Design Specification Design Review Programming Standards Code Review Data Migration Test Plan Factory Acceptance Testing Protocol / Report Installation Qualification Protocol / Report Unit and Integration Testing Protocol / Report Required? (Yes / No) Complete? (x / ) Page 11 of 14
12 Deliverable System Test Protocol / Report Operational Qualification Protocol / Report Acceptance Test Protocol / Report Performance Qualification Protocol / Report System Operating Procedures / User Manuals Training System Support Plan Service Level Agreement (SLA) Handover System Release Deployment Planning Validation Report Operation Phase Continuity Planning / Testing / Disaster Recovery Periodic Review Data Archive & Retrieval Backup and Restore Retirement Phase Decommissioning Plan / Report Required? (Yes / No) Complete? (x / ) Page 12 of 14
13 References ISPE GAMP 5, 2008, A Risk-Based Approach to Compliant GxP Computerized Systems. Sources Links used within this document are prone to change. Please refer to the appropriate source for the most recent information. We endeavour to keep an up-to-date record of information at Page 13 of 14
14 PharmOut is an international GMP consultancy serving the Pharmaceutical, Medical Device and Veterinary industries. PharmOut specialises in PIC/S, WHO, United States FDA, European EMA, and Australian TGA GMP consulting, engineering, project management, training, validation, continuous improvement and regulatory services. Our team includes international GMP experts who have previously held leadership roles within regulatory bodies. For more information please visit or contact us at Page 14 of 14
This interpretation of the revised Annex
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation
More informationTesting Automated Manufacturing Processes
Testing Automated Manufacturing Processes (PLC based architecture) 1 ❶ Introduction. ❷ Regulations. ❸ CSV Automated Manufacturing Systems. ❹ PLCs Validation Methodology / Approach. ❺ Testing. ❻ Controls
More informationGAMP 4 to GAMP 5 Summary
GAMP 4 to GAMP 5 Summary Introduction This document provides summary information on the GAMP 5 Guide and provides a mapping to the previous version, GAMP 4. It specifically provides: 1. Summary of Need
More informationWhite paper: How to implement a Quality Management System
White paper: How to implement a Quality Management System This whitepaper will help you to implement a Quality Management System (QMS), based on Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485
More informationWhite paper: FDA Guidance for Industry Update Process Validation
White paper: FDA Guidance for Industry Update Process Validation In January 2011, the FDA released the final version of its long-awaited update to its Process Validation Guidance for Industry. Since then,
More informationCONTENTS. List of Tables List of Figures
Prelims 13/3/06 9:11 pm Page iii CONTENTS List of Tables List of Figures ix xi 1 Introduction 1 1.1 The Need for Guidance on ERP System Validation 1 1.2 The Need to Validate ERP Systems 3 1.3 The ERP Implementation
More informationServices Providers. Ivan Soto
SOP s for Managing Application Services Providers Ivan Soto Learning Objectives At the end of this session we will have covered: Types of Managed Services Outsourcing process Quality expectations for Managed
More informationImplementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title
More informationConsiderations When Validating Your Analyst Software Per GAMP 5
WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist
More informationNew changes to cleanroom & clean air device classifications: ISO 14644 1 & 2
New changes to cleanroom & clean air device classifications: ISO 14644 1 & 2 This white paper describes the changes outlined in the Draft International Standard (DIS) editions of ISO 14644-1 and ISO 14644-2.
More informationINTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to
INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software
More informationQualification Guideline
Qualification Guideline June 2013 Disclaimer: This document is meant as a reference to Life Science companies in regards to the Microsoft O365 platform. Montrium does not warrant that the use of the recommendations
More informationValidating Enterprise Systems: A Practical Guide
Table of Contents Validating Enterprise Systems: A Practical Guide Foreword 1 Introduction The Need for Guidance on Compliant Enterprise Systems What is an Enterprise System The Need to Validate Enterprise
More informationComputer System Configuration Management and Change Control
Computer System Configuration Management and Change Control Using Risk-Based Decision Making to Plan and Implement IT Change Justin J. Fisher Senior Manager, BT Quality and Compliance Pfizer Agenda 1.
More informationDomain 1 The Process of Auditing Information Systems
Certified Information Systems Auditor (CISA ) Certification Course Description Our 5-day ISACA Certified Information Systems Auditor (CISA) training course equips information professionals with the knowledge
More informationComputer System Configuration Management and Change Control
Computer System Configuration Management and Change Control What Your IT Department Is Really Doing Justin J. Fisher, Pfizer IT Quality and Compliance Manager Agenda 1. Background 2. Audience Demographics
More informationHow to implement a Quality Management System
How to implement a Quality Management System This whitepaper will help you to implement a Quality Management System (QMS), based on Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485 within your
More informationComputerised Systems. Seeing the Wood from the Trees
Computerised Systems Seeing the Wood from the Trees Scope WHAT IS A COMPUTERISED SYSTEM? WHY DO WE NEED VALIDATED SYSTEMS? WHAT NEEDS VALIDATING? HOW DO WE PERFORM CSV? WHO DOES WHAT? IT S VALIDATED -
More informationInternal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization
Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context
More informationRisk-Based Validation of Computer Systems Used In FDA-Regulated Activities
September 2, 2003 Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities Purpose This document provides a summary of the requirements relating to use of computer-based systems in activities
More informationMHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
More informationSYLOGENT DEDICATED HOSTING
HOSTING & PROCESS SYLOGENT DEDICATED HOSTING VM VM VM VM VM VM VM VM VM VM VM VM VM VM VM HYPERVISOR HYPERVISOR HYPERVISOR DB1 active DB2 passive Clustered hypervisors that host dedicated VMs integrated
More information(COMPANY LOGO) CGMP COMPUTERIZED SYSTEM VENDOR AUDIT QUESTIONNAIRE
1. GENERAL COMPANY INFORMATION (COMPANY LOGO) 1.1 Name Address Years in Business Number of Employees Services Performed or Products Manufactured Prior Experience with (Company Name) 1.2 Please provide
More informationMHRA GMP Data Integrity Definitions and Guidance for Industry January 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
More informationIT General Controls Domain COBIT Domain Control Objective Control Activity Test Plan Test of Controls Results
Acquire or develop application systems software Controls provide reasonable assurance that application and system software is acquired or developed that effectively supports financial reporting requirements.
More informationSTS Federal Government Consulting Practice IV&V Offering
STS Federal Government Consulting Practice IV&V Offering WBE Certified GSA Contract GS-35F-0108T For information Please contact: gsa70@stsv.com 2007 by STS, Inc. Outline Background on STS What is IV&V?
More informationConsiderations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide
WHITE PAPER SDS Software v2.x Enterprise Edition Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide This white paper describes
More informationISO 20000-1:2005 Requirements Summary
Contents 3. Requirements for a Management System... 3 3.1 Management Responsibility... 3 3.2 Documentation Requirements... 3 3.3 Competence, Awareness, and Training... 4 4. Planning and Implementing Service
More informationComputer System Validation - It s More Than Just Testing
Computer System Validation - It s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application
More informationThe FDA recently announced a significant
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
More information074-8432-552 Page 1 of 7 Effective Date: 12/18/03 Software Supplier Process Requirements
Page 1 of 7 Software Supplier Process Requirements 1.0 QUALITY SYSTEM FRAMEWORK 1.1 QUALITY POLICY The Seller shall document and implement a quality program in the form of Quality manual or detailed Quality
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products
More informationCompliance Response SIMATIC SIMATIC PCS 7 V8.1. Electronic Records / Electronic Signatures (ERES) Edition 03/2015. Answers for industry.
SIMATIC SIMATIC PCS 7 V8.1 Electronic Records / Electronic Signatures (ERES) Compliance Response Edition 03/2015 Answers for industry. Compliance Response Electronic Records / Electronic Signatures (ERES)
More informationISO 9001:2000 AUDIT CHECKLIST
ISO 9001:2000 AUDIT CHECKLIST No. Question Proc. Ref. Comments 4 Quality Management System 4.1 General Requirements 1 Has the organization established, documented, implemented and maintained a quality
More informationITIL A guide to service asset and configuration management
ITIL A guide to service asset and configuration management The goal of service asset and configuration management The goals of configuration management are to: Support many of the ITIL processes by providing
More informationISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR
Page 1 of 20 ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR SUPPLIER/ SUBCONTRACTOR NAME: ADDRESS: CITY AND STATE: ZIP CODE: SUPPLIER/MANUFACTURER NO PHONE: DIVISION:
More informationCloud Computing in GxP Environment
Cloud Computing in GxP Environment Kathy Gniecko Hoffmann LaRoche 3rd April 2014, Stevenage 1 Introductions 18 years Experience in Pharma across all aspects of CSV. Prior to CSV experience in Pharma Research,
More informationOECD DRAFT ADVISORY DOCUMENT 16 1 THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS FOREWARD
OECD DRAFT ADVISORY DOCUMENT 16 1 THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS FOREWARD 1. The following draft Advisory Document will replace the 1995 OECD GLP Consensus Document number 10
More informationOMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (08) 69 3R Full document title and reference Document type VALIDATION OF COMPUTERISED SYSTEMS Legislative basis - CORE DOCUMENT
More informationCloud Computing: What needs to Be Validated and Qualified. Ivan Soto
Cloud Computing: What needs to Be Validated and Qualified Ivan Soto Learning Objectives At the end of this session we will have covered: Technical Overview of the Cloud Risk Factors Cloud Security & Data
More informationGuidance for Industry: Quality Risk Management
Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. What is risk?... 4 5. Integrating
More informationThe Configuration Management process area involves the following:
CONFIGURATION MANAGEMENT A Support Process Area at Maturity Level 2 Purpose The purpose of is to establish and maintain the integrity of work products using configuration identification, configuration
More informationComputer System Validation for Clinical Trials:
Computer System Validation for Clinical Trials: Framework Standard Operating Procedure (F-SOP) Author: Tim Cross Version History: 0.1di DRAFT 24-April-2013 0.2 DRAFT 12-June-2013 Current Version: 1.0 17-June-2013
More informationunless the manufacturer upgrades the firmware, whereas the effort is repeated.
Software Validation in Accredited Laboratories A Practical Guide Gregory D. Gogates Fasor Inc., 3101 Skippack Pike, Lansdale, Pennsylvania 19446-5864 USA g.gogates@ieee.org www.fasor.com Abstract Software
More informationRequirements Analysis/Gathering. System Requirements Specification. Software/System Design. Design Specification. Coding. Source Code.
Change Control and Configuration Management IVT 11 th Annual conference April 2010 DISCLAIMER Amgen is not responsible for the written or verbal bl content t of fthi this presentation tti Gisele Fahmi,
More informationCompliance Response Edition 07/2009. SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures. simatic wincc DOKUMENTATION
Compliance Response Edition 07/2009 SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures simatic wincc DOKUMENTATION Compliance Response Electronic Records / Electronic Signatures
More informationInformation Security Policies. Version 6.1
Information Security Policies Version 6.1 Information Security Policies Contents: 1. Information Security page 3 2. Business Continuity page 5 3. Compliance page 6 4. Outsourcing and Third Party Access
More informationISO 9001:2008 Audit Checklist
g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation
More informationClinical database/ecrf validation: effective processes and procedures
TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized
More informationFrom Chaos to Clarity: Embedding Security into the SDLC
From Chaos to Clarity: Embedding Security into the SDLC Felicia Nicastro Security Testing Services Practice SQS USA Session Description This session will focus on the security testing requirements which
More informationSharon Strause 9/10/2010. 15 years with the
Manage Software Development, Testing, and Validation Presented by Sharon Strause, Senior Consultant EduQuest, Inc. IVT s Computer and Software Validation EU Conference The Hilton Dublin Dublin, Ireland
More informationInformation Technology Engineers Examination. Information Security Specialist Examination. (Level 4) Syllabus
Information Technology Engineers Examination Information Security Specialist Examination (Level 4) Syllabus Details of Knowledge and Skills Required for the Information Technology Engineers Examination
More informationComputerized System Audits In A GCP Pharmaceutical Laboratory Environment
IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data
More informationPHASE 9: OPERATIONS AND MAINTENANCE PHASE
PHASE 9: OPERATIONS AND MAINTENANCE PHASE During the Operations and Maintenance Phase, the information system s availability and performance in executing the work for which it was designed is maintained.
More informationISO 9001:2000 Gap Analysis Checklist
ISO 9001:2000 Gap Analysis Checklist Type: Assessor: ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS 4 Quality Management System 4.1 General Requirements Processes needed for the quality management system
More informationINTEGRATED MANAGEMENT SYSTEM MANUAL IMS. Based on ISO 9001:2008 and ISO 14001:2004 Standards
INTEGRATED MANAGEMENT SYSTEM MANUAL IMS Based on ISO 9001:2008 and ISO 14001:2004 Standards Approved by Robert Melani Issue Date 30 December 2009 Issued To Management Representative Controlled Y N Copy
More informationWelcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014
Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing
More informationITIL Introducing service transition
ITIL Introducing service transition The goals of service transition Aligning the new or changed service with the organisational requirements and organisational operations Plan and manage the capacity and
More informationGAMP5 - a lifecycle management framework for customized bioprocess solutions
GE Healthcare Life Sciences GAMP5 - a lifecycle management framework for customized bioprocess solutions imagination at work GE Healthcare s engineering department, Customized Bioprocess Solutions (CBS),
More informationOrganisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development
Unclassified ENV/JM/MONO(2016)13 ENV/JM/MONO(2016)13 Unclassified Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 22-Apr-2016 English
More informationSaaS Adoption Lifecycle in Life-Sciences Companies
www.arisglobal.com A White Paper Presented By ArisGlobal SaaS Adoption Lifecycle in Life-Sciences Companies by Achal Verma, Associate Director - Program Delivery, Cloud Services Abstract With increasing
More informationOH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable)
OH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable) 4.1 General Requirements 4.2 OHS policy Has the organisation an established and maintained
More informationGuidance for Industry Computerized Systems Used in Clinical Investigations
Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance
More informationOverview of STS Consulting s IV&V Methodology
Overview of STS Consulting s IV&V Methodology STS uses a 5 Step Methodology for IV&V. Our risk-based methodology conforms to Best Practices, relevant international standards, and regulations/guidelines
More informationInformation Security Policy September 2009 Newman University IT Services. Information Security Policy
Contents 1. Statement 1.1 Introduction 1.2 Objectives 1.3 Scope and Policy Structure 1.4 Risk Assessment and Management 1.5 Responsibilities for Information Security 2. Compliance 3. HR Security 3.1 Terms
More informationTitle: Rio Tinto management system
Standard Rio Tinto management system December 2014 Group Title: Rio Tinto management system Document No: HSEC-B-01 Standard Function: Health, Safety, Environment and Communities (HSEC) No. of pages: 23
More informationCommonwealth of Massachusetts IT Consolidation Phase 2. ITIL Process Flows
Commonwealth of Massachusetts IT Consolidation Phase 2 ITIL Process Flows August 25, 2009 SERVICE DESK STRUCTURE Service Desk: A Service Desk is a functional unit made up of a dedicated number of staff
More informationGatekeeper PKI Framework. February 2009. Registration Authority Operations Manual Review Criteria
Gatekeeper PKI Framework ISBN 1 921182 24 5 Department of Finance and Deregulation Australian Government Information Management Office Commonwealth of Australia 2009 This work is copyright. Apart from
More informationChecklist. Standard for Medical Laboratory
Checklist Standard for Medical Laboratory Name of hospital..name of Laboratory..... Name. Position / Title...... DD/MM/YY.Revision... 1. Organization and Management 1. Laboratory shall have the organizational
More informationComputer and Software Validation Volume II
Table of Contents Maintaining the Validated State in Computer Systems Orlando Lopez Use Automated Testing Tools? Janis V. Olson Considerations for Validation of Manufacturing Execution Systems Chris Wubbolt
More informationDigital Continuity in ICT Services Procurement and Contract Management
Digital Continuity in ICT Services Procurement and Contract Management This guidance relates to: Stage 1: Plan for action Stage 2: Define your digital continuity requirements Stage 3: Assess and manage
More informationPHASE 5: DESIGN PHASE
PHASE 5: DESIGN PHASE During the Design Phase, the system is designed to satisfy the requirements identified in the previous phases. The requirements identified in the Requirements Analysis Phase are transformed
More informationQuality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle
Quality Risk Management 11 November 2011 Galway, Ireland Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle Overview Regulatory
More informationPlanning/Administrative. Management & Organization. Application Level Accuracy and Completeness. EDI Systems Audit Program
EDI Systems Audit Program A Planning/Administrative 1 Review the Letter of Understanding and create the APM (Audit Planning Memorandum) accordingly. A-1 DB 02/03 2 Gain a high-level understanding of Auditee
More informationTechnology Update. Validating Computer Systems, Part 3. 2. System plan URS SLA
Technology Update Validating Computer Systems, Part 3 GCP Software Verification Teri Stokes Writing software for GCP use is serious business. Applications must be tested and retested to ensure that they
More informationISO 9001:2008 Quality Management System Requirements (Third Revision)
ISO 9001:2008 Quality Management System Requirements (Third Revision) Contents Page 1 Scope 1 1.1 General. 1 1.2 Application.. 1 2 Normative references.. 1 3 Terms and definitions. 1 4 Quality management
More informationISMS Implementation Guide
atsec information security corporation 9130 Jollyville Road, Suite 260 Austin, TX 78759 Tel: 512-615-7300 Fax: 512-615-7301 www.atsec.com ISMS Implementation Guide atsec information security ISMS Implementation
More information8. Master Test Plan (MTP)
8. Master Test Plan (MTP) The purpose of the Master Test Plan (MTP) is to provide an overall test planning and test management document for multiple levels of test (either within one project or across
More informationInformation Systems and Technology
As public servants, it is our responsibility to use taxpayers dollars in the most effective and efficient way possible while adhering to laws and regulations governing those processes. There are many reasons
More informationService Definition Document
Service Definition Document QinetiQ Secure Cloud Protective Monitoring Service (AWARE) QinetiQ Secure Cloud Protective Monitoring Service (DETER) Secure Multi-Tenant Protective Monitoring Service (AWARE)
More informationNewcastle University Information Security Procedures Version 3
Newcastle University Information Security Procedures Version 3 A Information Security Procedures 2 B Business Continuity 3 C Compliance 4 D Outsourcing and Third Party Access 5 E Personnel 6 F Operations
More informationManaging & Validating Research Data
Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical
More informationSoftware Test Plan (STP) Template
(STP) Template Items that are intended to stay in as part of your document are in bold; explanatory comments are in italic text. Plain text is used where you might insert wording about your project. This
More informationChallenges and Benefits of Agile Practices Implementation - A Pharma Industry Adaptation Strategic and Innovative Practices
Title of the Paper: Theme: Challenges and Benefits of Agile Practices Implementation - A Pharma Industry Adaptation Strategic and Innovative Practices Keywords: Agile, Pharma, Regulatory Compliance, Project
More informationSystem Build 2 Test Plan
System Build 2 Test Plan Version 1.0 System Build 2 Test Plan Author s Signature Your signature indicates that this document has been prepared with input from content experts and is in compliance with
More informationA Pragmatic Approach to the Testing of Excel Spreadsheets
A Pragmatic Approach to the Many GxP critical spreadsheets need to undergo validation and testing to ensure that the data they generate is accurate and secure. This paper describes a pragmatic approach
More informationProject Management Guidelines
Project Management Guidelines 1. INTRODUCTION. This Appendix (Project Management Guidelines) sets forth the detailed Project Management Guidelines. 2. PROJECT MANAGEMENT PLAN POLICY AND GUIDELINES OVERVIEW.
More informationComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013
TM ComplianceSP TM on SharePoint Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 Overview With increasing pressure on costs and margins across Life Sciences, the industry
More informationINFORMATION TECHNOLOGY CONTROLS
CHAPTER 14 INFORMATION TECHNOLOGY CONTROLS SCOPE This chapter addresses requirements common to all financial accounting systems and is not limited to the statewide financial accounting system, ENCOMPASS,
More informationImplementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.
Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.. www.pharmout.net Page 1 of 15 Version-02 1. Scope 1.1. Purpose This paper reviews the implementation of the ANSI/AAMI/IEC
More informationMonitoring the autoclaving process in the pharmaceutical industry
Application Description AD/RandC/006-EN Monitoring the autoclaving process in the pharmaceutical industry - Provides independent verification and validation monitoring of the autoclaving process - Enables
More informationDomain Name Service Service Level Agreement (SLA) Vanderbilt Information Technology Services
Service Level Agreement Page 1 of 7 Domain Name Service Service Level Agreement (SLA) Vanderbilt Information Technology Services 1. Agreement This agreement is to define Domain Name Service (DNS) provided
More informationSummary of CIP Version 5 Standards
Summary of CIP Version 5 Standards In Version 5 of the Critical Infrastructure Protection ( CIP ) Reliability Standards ( CIP Version 5 Standards ), the existing versions of CIP-002 through CIP-009 have
More informationService Level Agreement for Database Hosting Services
Service Level Agreement for Database Hosting Services Objective Global Service Levels include the general areas of support that are applicable to every ITS service. The purpose of the Service Level Agreement
More informationFull Compliance Contents
Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex
More informationISO/IEC 17025 QUALITY MANUAL
1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4
More information<name of project> Software Project Management Plan
The document in this file is adapted from the IEEE standards for Software Project Management Plans, 1058-1998, which conforms to the requirements of ISO standard 12207 Software Life Cycle Processes. Tailor
More informationREGULATIONS COMPLIANCE ASSESSMENT
ALIX is free software: you can redistribute it and/or modify it under the terms of the GNU General Public License as published by the Free Software Foundation. REGULATIONS COMPLIANCE ASSESSMENT BUSINESS
More informationSupplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002)
Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002) Supplier: Plant/Location: Date: Audit Team: Scope of Audit: Number of C.A.R. s: Corrective Action Due: Potential suppliers
More information